Kornimate/medical-research-clean huggingface dataset:
expanded access to bimatoprost (durysta)

Conditions: Open-angle Glaucoma

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to durysta (bimatoprost) prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: * the participant must not be eligible for bimatoprost implant (durysta) clinical trial. * eligibility for this program is limited to patients with moderate or worse glaucoma who are at risk of severe visual impairment based on physician assessment of risk factors associated with visual field progression as defined by the respective country/regional glaucoma clinical practice guidelines (eg, canadian ophthalmological society guidelines, european glaucoma society guidelines, etc.), and who have exhausted all the appropriate pharmaceutical treatment options and are contraindicated for surgery, which may include: * patients with ocular comorbidities such as severely scarred conjunctiva (eg, chemical burns, stevens-johnson syndrome), scleral thinning. * patients who are intolerant to any pre- , intra-, or post-op treatments (e.g allergy/intolerance to medical treatments or to anesthesia). * patients with systemic comorbidities (e.g cardiovascular conditions) in which any surgery is not recommended

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
changes of oral and intestinal microbiota after bariatric surgery

Conditions: Morbid Obesity

Summary: purpose the aim of this study was to analyze the changes of microbiota among patients undergoing lsg or lrygb on two levels of gastrointestinal tract (using oral swab and stool sample). we compared samples from patients before and after bariatric operation. materials and methods this prospective cohort study was conducted in one academic, teaching hospital. the recommendations of the metabolic and bariatric surgery section of the polish surgical society were used as indication for surgery, that is: body mass index (bmi) ≥35 kg/m2 with obesity-related comorbidities or bmi ≥40 kg/m2. analysis and endpoints primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients before and after bariatric surgery. secondary endpoint was to compare the difference in microbiota changes between patients undergoing lsg and lrygb


Eligibility criteria:
inclusion criteria: * informed consent to participate in the study * meeting the eligibility criteria for bariatric treatment (either for lsg or lrygb). exclusion criteria: * treatment with antibiotics within 30 days prior to gathering microbiological material * gastrointestinal infections * inflammatory bowel disease * thyroid diseases * cancer (especially the digestive tract) * immunodeficiency.
a study to identify and characterise patients with chronic kidney disease and proteinuria

Conditions: Renal Disease

Summary: the purpose of the d4325c00007 study is to identify and characterise patients with known or newly diagnosed ckd for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions.


Eligibility criteria:
inclusion criteria: 1. male or female aged ≥ 18 years at the time of signing the informed consent 2. express interest to participate in a future ckd clinical study 3. egfr ≥ 20 to \< 90 ml/min/1.73 m2 (egfrcr\[as\], section 8.2.1) (delgado et al 2022, inker et al. 2021) 4. uacr ≥ 700 mg/g or upcr ≥ 1000 mg/g based on urine sample at time of screening visit 5. receiving ras inhibitor therapy (acei or arb) that has been at stable dosing for at least 4 weeks. exceptions from this requirement will be made for participants who are unable to tolerate ras inhibitor therapy 6. provision of signed and dated written informed consent before any study-specific procedures exclusion criteria: 1. known nyha class iii or class iv congestive heart failure at the time of enrolment 2. known t1dm 3. known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal) 4. known history of solid organ transplantation 5. known history or ongoing allergy/hypersensitivity, as judged by the investigator, to sglt2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan) 6. known blood-borne diseases such as specified in appendix b (category a and b) 7. known pregnancy at the time for the visit or have an intention to become pregnant 8. lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema

Keywords: high proteinuria
a novel lung function imaging modality as a preoperative evaluation tool (lime)

Conditions: Lung Cancer

Summary: to evaluate the correlation between pre-surgical 4dct-ventilation imaging and post-surgical lung function.

to evaluate the correlation between pre-surgical 4-dimensional computed tomography-ventilation (4dct-ventilation) imaging and post-surgical lung function. to determine whether 4dct-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (pfts). to determine whether 4dct-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (qol) questionnaires. evaluate cost-effectiveness of using 4dct-ventialtion and vq scans for pre-surgical assessment. to use longitudinal (pre and post-surgical) 4dct-ventilation imaging to derive novel post-surgical prediction formulas.

Eligibility criteria:
inclusion criteria: 1. provision to sign and date the consent form. 2. stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study. 3. be a male or female aged 18 to 100. 4. patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection. 5. lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon. 6. life expectancy greater than 3 months. exclusion criteria: 1. patients getting a planned wedge resection as the only thoracic resectional procedure.

Keywords: 4-dimensional computed tomography
cardiovascular risk factors after renal transplantation in children and adults

Conditions: Exercise Capacity; Physical Activity; Hypertension; Overweight and Obesity; Metabolic Syndrome

Summary: renal transplantation of children started in norway in 1970.since the beginning, \>80% of renal transplants are provided from living donors(mainly parents), short pre-transplant dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is needed.this gives good premises for graft survival and avoidance of detrimental effects of dialysis. however, renal transplanted children are subjected to an increased cardiovascular morbidity and mortality in adulthood due to consequences of chronic renal failure and immunosuppressive treatment.cardiovascular death comprises 30-40% of death causes. in this cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young adults renal transplanted in childhood. focus is cardiorespiratory fitness using treadmill testing,24h bp measurements, anthropometrics including waist circumference,echocardiography,intima media thickness of carotids, glucose intolerance test.participants are also requested to fill out physical activity recalls and quality of life questionnaires.


Eligibility criteria:
inclusion criteria: * transplanted after 1983, functioning graft exclusion criteria: * patients in dialysis * in part of the study concerning treadmill testing: age\<8 years, orthopedic limitations

Keywords: cardiorespiratory fitness physical activity hypertension overweight and obesity metabolic syndrome body composition
reconstruction of complex proximal humeral fractures.

Conditions: Osteoarthritis of the Shoulder; Complexe Proximal Humeral Fractures

Summary: the purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3d planning compared to conventional 2d planning.


Eligibility criteria:
inclusion criteria: * osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty * patients \> 18years exclusion criteria: * contraindication for computertomography * pregnancy * previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture

Keywords: osteoarthritis complexe proximal humeral fracture shoulder shoulder replacement accuracy computer-assisted 3d
intrathecal hydromorphone for labor analgesia

Conditions: Labor Pain

Summary: this study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). the primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. secondary objectives include determining this dose at five and ten minutes after injection. thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. the starting dose of intrathecal hydromorphone will be 6 mcg. the up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone. after the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. a pain score of less than three will be a positive result. a pain score of three or greater will be a negative result. blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.


Eligibility criteria:
inclusion criteria: * healthy patients * labor * desires pain relief exclusion criteria: * any comorbidities other than obesity
drawing the line between medium care and intensive care. a prospective observational study based on the nursing activities score

Conditions: Critical Illness

Summary: the aim of the study is to develop a screening instrument, based on the nursing activities score, by which we can distinguish medium care patients from the intensive care patients in terms of nurse staffing. the main study question is: what is the most discriminative nas cut off for medium care patient? each nursing shift the nas and tiss 28 scores will be calculated for each patient who is admitted to the 8 participating units. nurses will be asked to answer 3 questions (see detailed description here under)at the end of their working shift concerning each patient appointed to them. each morning medical staff and head nurses will be asked 2 questions (see detailed description here under) for concerning patient admitted to there ward. in order to determine the nas cut off for medium care patient, all morning questionnaire scores will be compared to the nas an tiss28 scores of that same morning. secondary study questions are: * can nas score based on one nursing shift predict the severity of care in the subsequent nursing shift? * is there a difference in appreciation of severity of care between nurses, head nurses and medical staff? * which variables influence the perception of severity of care? * how does nas relate to tiss28, apache and nems?

nursing questionnaire: 1. how many beds were appointed to you? 1. 1 2. 2 3. 3 4. 4 5. 5 6. 6 2. for how many of such patients you could care for maximally? 1. 1 2. 2 3. 3 4. 4 5. \>4 3. this patients' burden of care corresponds to: 1. an intensive care patient who requires more than standard intensive care 2. an intensive care patient who requires standard intensive care 3. a medium care patient medical staff and head nurse questionaire: 1. for how many of such patients you could care for maximally? 1. 1 2. 2 3. 3 4. 4 5. \>4 2. this patients' burden of care corresponds to? 1. an intensive care patient who requires more than standard intensive care 2. an intensive care patient who requires standard intensive care 3. a medium care patient

Eligibility criteria:
inclusion criteria: * admission to one of the 9 critical area's

Keywords: severity of illness scoring medium care intensive care staffing
the effect of virtual reality application on pain due to fistula puncture in hemodialysis patients

Conditions: Chronic Kidney Diseases

Summary: the aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (fpi-a) in hemodialysis patients. hypotheses of the research: h0-1: virtual reality application has an effect on fistula puncture-related pain in hd patients. h1-2: virtual reality application has no effect on fistula puncture-related pain in hd patients. in the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

* demographic/medical data will initially be recorded prior to fistula puncture. * the patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position. * virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started. * the patient will continue to monitor the virtual reality application during the fistula puncture procedure. it will be ensured that no communication with the patient is made until the application is finished. * the application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.

Eligibility criteria:
inclusion criteria: * no diagnosis of neuropathic pain * no sedatives, analgesics and sedatives are applied 3 hours before the application. * not taking recently taken antipsychotic drugs and tranquilizers, * deaf and visually impaired (to mark vas pain) * without cognitive and psychiatric diagnosis * open to communication and cooperation * patients who agreed to participate in the study exclusion criteria: * kidney transplant * discomfort due to virtual reality glasses * suspected/diagnosed covid-19 * patients who want to leave the study voluntarily * death * multiple fistula puncture attempts
osteonecrosis of the jaw (onj) case registry

Conditions: Osteonecrosis of the Jaw

Summary: osteonecrosis of the jaw (onj) case registry

the purpose of the onj case registry is to describe the natural history of positively-adjudicated onj in subjects with cancer with an observation period of 5 years. most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). it is also possible that the registry will include subjects with cancer who developed onj without exposure to any antiresorptive therapy.

Eligibility criteria:
inclusion criteria: * adult (≥18 years of age) with diagnosis of cancer * newly diagnosed, positively-adjudicated onj * ecog \<=2 and expected survival ≥3 months * willing to provide access to previous and future medical and dental information * subject or subject's legally acceptable representative has provided written informed consent exclusion criteria: * history of radiation to the jaws administered for the treatment of cancer * subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge. * subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
a phase iia study assessing the effects of azd1236 on biomarkers in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary aim of this study is to investigate the effects of azd1236 compared with placebo ("inactive substance") in copd patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.


Eligibility criteria:
inclusion criteria: * diagnosis of copd for 1 month * men or postmenopausal women * spirometry values indicating symptomatic patients * smoking history equivalent to using 20 cigarettes a day for 10 years. exclusion criteria: * any current respiratory tract disorders other than copd * requirement for regular oxygen therapy * acute worsening of copd (exacerbation) 1,5 month prior to study drug administration * use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Keywords: copd
associations between depression and cardiovascular disease - a study of patients with late onset depression

Conditions: Depression; Major Depressive Disorder; Cardiovascular Disease; Coronary Artery Disease

Summary: studies show that depression is a risk factor for the development of coronary artery disease (cad). furthermore there is an increased occurrence of depression in patients with cad. among other mechanisms atherosclerosis is believed to play a central role regarding these notable associations between depression and cad. moreover, patients with late onset major depression have an increased number of small lesions found in the white matter of the brain, the so-called white matter lesions. the main goal of this project is to examine if cad is associated with depression and/or white matter lesions. cad is evaluated using coronary ct angiography. depression is evaluated using a semi-structured diagnostic interview. white matter lesions are quantified using cerebral magnetic resonance.


Eligibility criteria:
inclusion criteria: * submitted to psychiatric hospital, district psychiatry or private psychiatrist because of major depressive disorder. * meets the criteria for major depressive disorder, single episode as defined in the diagnostic and statistical manual, fourth edition (dsm-iv) and the international classification of diseases (icd-10). * age 50-70 years. * written informed consent. * caucasian. exclusion criteria: * known, or anamnestic/objective signs of, organic brain disease. * organic, including symptomatic, mental disorders as (icd-10: f00-f09). * dependence syndrome within the last 5 years (icd-10: f1x.2) or current harmful use (icd-10: f1x.1) of alcohol or other psychoactive substances. * schizophrenia, schizotypal and delusional disorders (icd-10: f20-f29). * subject to force of law according to the danish law on psychiatry. * present risk of suicide. * previous cranial trauma resulting in unconsciousness for more than 2 minutes. * medical history of renal failure. * other conditions which contraindicate specific procedures in the project. * other conditions deemed to prevent the subject from completing the examination program. * does not want to participate.

Keywords: depression major depressive disorder coronary artery disease white matter hyperintensities white matter lesions coronary artery calcification
functional brain imaging in recreational users of ecstasy

Conditions: Amphetamine-Related Disorders

Summary: recreational use of "ecstasy" (mdma; 3,4-methylenedioxymethamphetamine) is associated with long-lasting effects on metabolism in the human brain. the investigators propose to investigate whether chronic use of "ecstasy" is associated with impairment in motor skills and function of the dopaminergic system in recreational users of "ecstasy" compared with healthy volunteers. this will be done by scanning control subjects and "ecstasy" users at baseline and after performing on a motorbike riding computer game, while imaging dopamine in vivo with i123-ibzm (a d2 receptor radiotracer), using single photon emission computed tomography (spect).

recreational use of "ecstasy" (mdma; 3, 4-methylenedioxymethamphetamine) is associated with long-lasting effects on metabolism in the human brain. in particular, there is evidence of long-term damage to the brains' neurotransmitter serotonin (5-ht). it is also known that chronic use of methamphetamine (which is similar in its chemical structure to "ecstasy") is linked to impaired cognitive and motor skills despite recovery of dopamine transporters (dat). we have investigated whether chronic use of "ecstasy" is causing any impairment in motor skills and function of the dopaminergic system in recreational users of "ecstasy". in our preliminary study, we have scanned control subjects and "ecstasy" users, at baseline and after performing on a motorbike riding computer game while imaging dopamine in vivo with \[123i\] ibzm (a d2 receptor radiotracer) in single photon emission computed tomography (spect). we showed: 1. lower measures of d2 at baseline in ecstasy users compared with control subjects, that means lower level of dopaminergic activity in "ecstasy" users. 2. significant displacement of \[123i\] ibzm by endogenous dopamine released during the game in healthy subjects unlike "ecstasy" users, that means that recreational users of "ecstasy" release much less natural dopamine. 3. no difference between the groups in performance (reaction time) on riding the game after a year of recovery. our results show preliminary evidence for dopaminergic deficiency in "ecstasy" users, a finding that has not been shown before. however, similar to other drugs of abuse, it is not known whether dopaminergic deficiency is the cause or consequence of the use of "ecstasy". we now propose to proceed to scan more recreational users of "ecstasy" in order to assess whether chronic use of "ecstasy" is associated with deficient dopaminergic neurotransmission in the brain.

Eligibility criteria:
inclusion criteria: * chronic users of ecstasy, and healthy controls, with no other diseases or drug abuse exclusion criteria: * pregnant and breast feeding women * aged below 18 * neurological disorders * drug abuse

Keywords: ecstasy d2 dopamine receptor ibzm mdma
evaluation of the clinical effectiveness of naso-alveolar molding (nam) versus computer aided design nam (cad/nam) in infants with bilateral cleft lip and palate: a randomized clinical trial

Conditions: Cleft Lip and Palate

Summary: bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical naso-alveolar molding (nam) using grayson method, gp 2 computer aided design nam (cad/nam). the aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.


Eligibility criteria:
inclusion criteria: • bilateral cleft lip and palate exclusion criteria: patients without cleft palate unilateral cleft lip patients having systemic medical problems that contraindicate nam treatment patients with history of previous presurgical infant orthopedics patients with history of any surgical procedures (ex: lip adhesion)